Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002
Reported: September 8, 2021 Initiated: July 27, 2021 #Z-2405-2021
Product Description
Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002
Reason for Recall
The sterile barrier seal may be compromised.
Details
- Recalling Firm
- Clarus Medical, Llc
- Units Affected
- 858 units
- Distribution
- Distribution in US - 18 accounts 1 foreign account
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002. Recalled by Clarus Medical, Llc. Units affected: 858 units.
Why was this product recalled? ▼
The sterile barrier seal may be compromised.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 8, 2021. Severity: Moderate. Recall number: Z-2405-2021.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11